| K-number | K251427 |
| Device name | EK MULTI ANGLED 30 ABUTMENT |
| Applicant | Hiossen, Inc. |
| Product code | NHA |
| Device class | Class II |
| Decision date | Jan 29, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.3630 |
The EK Multi Angled 30 Abutment is a dental implant abutment manufactured from titanium alloy (Ti6Al-4V) that provides support for prosthetic restorations such as crowns, bridges, and overdentures in patients with partial or complete tooth loss. It is used with EK Dental Implants and is delivered non-sterilized, allowing users to steam sterilize it before use.
The device features a 30-degree angulation, a 4.8 mm diameter, and is available in three lengths (7.30, 7.80, and 8.80 mm). It has a hexagonal connection interface and a machine-finished surface. The primary difference from the predicate EK Dental Abutment is the 30-degree angle versus the predicate's 17-degree angle.
ISO 14801 (Dynamic fatigue test for endosseous dental implants), ISO 17665-1 (Sterilization of health care products — Moist heat requirements), and ISO 10993 (Biological evaluation of medical devices).
View the full FDA submission: accessdata.fda.gov